510(k) K954926

HM-CAP CONTROL PANEL by E-Z-Em, Inc. — Product Code LYR

K954926 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "HM-CAP CONTROL PANEL". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.